MECKI-Amyloidosis: Assessment of the Exercise Capacity and Prognosis of Patients with Cardiac Amyloidosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorCentro Cardiologico Monzino

About this trial

This study aims to advance the understanding of cardiac amyloidosis, its effects on exercise capacity, and its prognostic implications. By conducting a systematic investigation with particular emphasis on longitudinal evaluation, we aim to provide valuable insights to guide clinical practice and improve the management of patients with cardiac amyloidosis.

Our study intends to follow patients for a period of two years, evaluating them every six months. This longitudinal approach allows us to monitor changes in exercise capacity and other relevant clinical parameters over time. Furthermore, it enables the development of a prognostic tool similar to the MECKI score, capable of assessing the risk of adverse events in patients with cardiac amyloidosis based on their exercise performance.

By comparing our results with data from heart failure patients already included in the MECKI score database, we also aim to highlight any differences in prognosis between patients with cardiac amyloidosis and those with general heart failure. Finally, we aim to characterize cardiac amyloidosis by differentiating it from general heart failure. By comparing our results with data from heart failure patients already included in the MECKI score database, we can clarify the distinct exercise limitations in cardiac amyloidosis and shed light on how they differ from more conventional heart failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Diagnosis of cardiac amyloidosis obtained by MRI or scintigraphy

Ability to perform a cardiopulmonary exercise test

Disqualifiers

severe obstructive pulmonary disease

exercise-induced angina

significant ECG changes

presence of clinical comorbidities that interfere with exercise performance

Trial population

Prospective Cohort: Patients with Diagnosis of cardiac amyloidosis. Retrospective cohort: Population of heart failure patients selected from the MECKI score database

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,400 Participants
are grouped into 2 trial groups
Group A: Amyloidosis patients (prospective cohort)
Group B: Heart Failure patients (retrospective cohort)

Trial outcomes

Primary outcomes

1

Evaluation of the parameters most closely correlated with two-year prognosis in patients with cardiac amyloidosis in order to create a specific risk score for these patients.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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